Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

NCT03665688 | Completed Results DMC FDA Device

• 1 other identifier: 18-0132
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 2

Brief Summary

The target population for our study is women who present for induction of labor. If there is a decision by the obstetrical team to place a mechanical dilator for cervical ripening, the obstetrical team will notify the research staff so that the patient may be screened for the study. If the subject is eligible for the trial, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent procedure. After informed consent is obtained and Dilapan-S is placed, the patient will be randomized to the Outpatient or the Inpatient group.

Conditions

Labor, Induced; Cervix Uteri-Diseases

Keywords

Cervical ripening; Labor induction; Outpatient; Mechanical; Hygroscopic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hospital Stay Longer Than 48 Hours

  Rate of hospital stay longer than 48 hours (from admission to discharge)

  72 hours or discharge home time, whichever occurs first

Secondary Outcomes (6)

• Number of Participants With Vaginal Deliveries 2-4 Days

  2-4 days

• Number of Participants With Vaginal Deliveries - 24 Hours

  24 hours

• Time From Hospital Admission to Active Stage of Labor

  1-2 days

• Change in Bishop Score From Insertion of Device to Extraction

  12 hours

• Number of Participants With Operative Vaginal Delivery

  1-4 days

Study Arms (2)

Outpatient Dilapan-S

EXPERIMENTAL

After Dilapan-S® placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L\&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours

Device: Outpatient Dilapan-S

Inpatient Dilapan-S

ACTIVE COMPARATOR

After Dilapan-S® placement, subjects will be admitted to L\&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.

Device: Inpatient Dilapan-S

Interventions

Outpatient Dilapan-S DEVICE

After Dilapan-S placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L\&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours. After the designated 12 hours' time or earlier, if indicated, subjects are to return and to be admitted to L\&D unit for standard protocol of labor induction.

Also known as: Outpatient cervical ripening with Dilapan-S

Outpatient Dilapan-S

Inpatient Dilapan-S DEVICE

After Dilapan-S placement, subjects will be admitted to L\&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.

Also known as: Inpatient cervical ripening with Dilapan-S

Inpatient Dilapan-S

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant woman whose plan of care is induction of labor
• Maternal age between 18 and 45 years
• Understanding and capable to sign informed consent
• Singleton pregnancy
• Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound)
• Live fetus in cephalic presentation
• Intact membranes
• Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced

You may not qualify if:

• Active labor
• Active genital herpes
• Chorioamnionitis
• Transfundal uterine or cervical surgery
• Previous cesarean delivery
• Non-reassuring fetal status
• Need for continuous maternal or fetal monitoring during ripening
• Contraindication for vaginal delivery
• Active vaginal bleeding
• Abnormal placental location or adherence (placenta previa or unresolved low lying placenta)
• Estimated fetal weight \> 5000 g (non diabetic) or \> 4500 g (diabetic)
• Intrauterine growth restriction (estimated fetal weight \<10 percentile)
• Oligohydramnios (amniotic fluid index \< 5cm or deep vertical pocket of \< 2 cm)
• Fetal anomaly
• Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Medicem International CR s.r.o.: collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

UTMB Galveston

Galveston, Texas, 77555, United States

Location

Related Publications (12)

• Thiery M, De Boever J, Merchiers E, Martens G. Hormones and cervical ripening. Am J Obstet Gynecol. 1989 May;160(5 Pt 1):1251-3. doi: 10.1016/0002-9378(89)90207-x. No abstract available.

  PMID: 2524974 BACKGROUND

• Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

  PMID: 30089070 BACKGROUND

• Wilkinson C, Adelson P, Turnbull D. A comparison of inpatient with outpatient balloon catheter cervical ripening: a pilot randomized controlled trial. BMC Pregnancy Childbirth. 2015 May 28;15:126. doi: 10.1186/s12884-015-0550-z.

  PMID: 26018581 BACKGROUND

• Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.

  PMID: 24824157 BACKGROUND

• Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.

  PMID: 23356673 BACKGROUND

• Kruit H, Heikinheimo O, Ulander VM, Aitokallio-Tallberg A, Nupponen I, Paavonen J, Rahkonen L. Foley catheter induction of labor as an outpatient procedure. J Perinatol. 2016 Aug;36(8):618-22. doi: 10.1038/jp.2016.62. Epub 2016 Apr 14.

  PMID: 27078202 BACKGROUND

• Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.

  PMID: 11704164 BACKGROUND

• Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.

  PMID: 29211328 BACKGROUND

• Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3.

  PMID: 30107363 BACKGROUND

• Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.

  PMID: 29889751 BACKGROUND

• Saad AF, Gavara R, Senguttuvan RN, Goncharov AD, Berry M, Eid J, Goldman B, Nutter A, Moutos CP, Wang AM, Saade GR. Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator: A Randomized Clinical Trial. Obstet Gynecol. 2022 Oct 1;140(4):584-590. doi: 10.1097/AOG.0000000000004942. Epub 2022 Sep 7.

  PMID: 36083097 DERIVED

• Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

  PMID: 32852803 DERIVED

Results Point of Contact

• Title: Antonio Saad Director of Clinical Research Division
• Organization: UTMB Galveston

afsaad@utmb.edu

409 772 0982

Study Officials

• Antonio Saad, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 11, 2018
• Study Start: November 7, 2018
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Locations

US (2)